FLUORESCITE Solution for injection Ref.[10815] Active ingredients: Fluorescein

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

FLUORESCITE (fluorescein injection, USP) 10% contains fluorescein sodium (equivalent to fluorescein 10% w/v). It is a sterile solution for use intravenously as a diagnostic aid. Its chemical name is spiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one, 3’6'-dihydroxy, disodium salt.

The active ingredient is represented by the chemical structure:

FLUORESCITE (fluorescein injection, USP) 10% is supplied as a sterile, unpreserved, unit dose aqueous solution, that has a pH of 8.0–9.8 and an osmolality of 572-858 mOsm/kg.

Active ingredient: fluorescein sodium

Inactive Ingredients: Sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection.

Dosage Forms and Strengths

Single use 5 mL vial containing 100 mg/mL fluorescein.

How Supplied

FLUORESCITE (fluorescein injection, USP) 10% is supplied in a single use 5 mL glass vial with a gray FluroTec coated chlorobutyl stopper and purple flip-off aluminum seal. The vial stopper is not made with natural rubber latex. The vial contains a sterile, red-orange solution of fluorescein sodium.

NDC 0065-0092-05
NDC 0065-0092-65

Distributed By: ALCON LABORATORIES, INC., Fort Worth, Texas 76134 USA

Drugs

Drug Countries
FLUORESCITE Canada, Estonia, Hong Kong, Japan, New Zealand, Turkey, United States

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